The present invention relates generally to fluid specimen containers and analytical testing methods for analyzing the contents of fluid specimens and, more specifically, to fluid specimen containers designed to transfer fluid to test strips or other containers for testing purposes.
Analysis of body fluids such as urine or blood typically involves a first step of collecting the fluid sample in a container and then removing a sample of the fluid from the container to analyze it in the desired test format. For example, the fluid is removed from the container using a pipette and is then applied to a chemical or immunoassay test strip. A serious problem with this approach is that the tester may become exposed to the bodily fluid during the removal or pipetting procedure and may become infected with agents contained in the fluid.
A variety of fluid collection devices have been devised to limit tester exposure by combining the test component with the container (see, e.g. U.S. Pat. Nos. 4,827,944; 4,976,923; 5,119,830; 5,595,187; 5,501,837; 5,429,804; and 6,974,606). These devices, however, have various design limitations. For example, in some designs, testing occurs immediately rather than when actually desired. In other designs, the tests are built into the lid of the container, requiring inversion of the device to enable the specimen to exit the storage compartment and contact the test component. Inverting the device, however, raises the possibility for accidental leakage and makes it difficult to control the volume of fluid that is released to the test strip. Such designs also have the potential to contaminate the main fluid compartment with test reagents that flow backward from the testing compartment.
Thus, a need exists for improved specimen fluid collection devices that provide controlled volumes of fluid to the test strips when desired, eliminate contamination by back flow, and avoid unduly exposing the tester to the liquid specimen.
The present invention is directed to solving the problem alluded to above. Briefly, the device comprises: (a) a first compartment for receiving a fluid specimen to be tested and including a cover lid for fluidly sealing the first compartment; (b) a fluid metering valve comprising an assembly bearing and a valve cylinder disposed therein and rotatable along its longitudinal axis, said cylinder having one or more wells formed on the surface of the cylinder, said wells in fluid connection with said first compartment when said valve is at a first valve position; and (c) a second compartment in fluid connection to said wells of said valve cylinder when said valve is at a second valve position, said second compartment designed to receive one or more reagent test strips for testing the specimen fluid.
Also provided are a variety of valve cylinder well designs, including use of multiple wells, variations in well positioning, variations in well dimensions and combinations of the above.
In another embodiment, the device comprises at least one additional fluid metering valve in fluid connection with the first compartment when said additional valve is in a first position and is in fluid connection with at least one additional second compartment when the additional valve is at a second valve position.
In other embodiments, fluid connection between the valve cylinder and the first or second compartment can be achieved by means of a passageway.
In yet another embodiment, the fluid metering valve is located within a support structure. The second compartment also may be formed within the support structure.
In other embodiments, access to the second compartment is controlled by a protective cover.
The device also may comprise: (a) a first compartment for receiving a fluid specimen to be tested and including means for fluidly sealing the first compartment; (b) a second compartment designed to receive one or more reagent test strips for testing the fluid specimen; (c) a fluid metering valve comprising a valve cylinder disposed therein and rotatable along its longitudinal axis, said cylinder having one or more wells formed on the surface; and (d) means for fluidly connecting the fluid metering valve to said first compartment at a first valve cylinder position and to said second compartment at a second valve position.
This device includes additional embodiments similar to those described above.
Also provided herein is a method for using the device to collect and test a fluid specimen. The method comprises using one or more reagent test strips that avoids exposing the tester to the collected fluid and contaminating the collected fluid with the test strips, the method comprising the steps of: (a) collecting a fluid specimen into the first compartment of the device of the present invention; (b) rotating the cylinder of the fluid metering valve of the device to a first valve position so that the one or more wells connected to the first compartment each fill with a volume of the fluid specimen suitable to perform the testing; (c) rotating the cylinder of the fluid metering valve following step (b) to the second valve position so that the one or more wells are connected to the second compartment; and (d) inserting the one or more test strips into said second compartment so that each test strip contacts a suitable volume of fluid accessible to the second compartment and thereby initiating the test, wherein a fluid specimen is tested using one or more reagent test strips.
In another embodiment, the method is used to measure the presence or amount of an analyte by immunoassay while in another embodiment, the fluid tested is urine.
These and still other embodiments are discussed in more detail below.